NCT00874874已完成2 期
Phase II Multicenter Stratified Study Evaluating the Efficacy and Toxicity of Sorafenib in Treating Locally Advanced or Metastatic Angiosarcomas That Are Not Accessible to Curative Surgery
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 20
- 主要终点
- Rate of non-progression at 9 months by RECIST criteria
研究概览
简要总结
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with angiosarcoma that is locally advanced, metastatic, or unable to be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine the rate of non-progression at 9 months in patients with unresectable, locally advanced, or metastatic angiosarcoma treated with sorafenib tosylate.
Secondary
- Determine the rate of non-progression at 60, 120, and 180 days.
- Determine the median time to progression.
- Determine overall survival.
- Determine the best response rate.
- Determine the clinical and biological factors that predict clinical benefit.
- Evaluate tolerability by NCI CTCAE v3.0.
- Correlate efficacy with plasma expression of genes implicated in controlling angiogenesis.
- Explore the tumor expression of these genes in tissue from a tumor bank.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed angiosarcoma
- •Locally advanced or metastatic disease
- •Unresectable disease
- •No Kaposi sarcoma, hemangiopericytoma, or hemangioendothelioma
- •Measurable tumor with at least 1 measurable lesion by RECIST criteria
- •Tumor in a previously irradiated area must not show progression
- •No brain metastases or meningeal tumors (symptomatic or asymptomatic)
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •Life expectancy ≥ 3 months
- •WBC ≥ 3,000/mm³
- •ANC ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 9 g/dL
- •PT or INR and aPTT ≤ 1.5 times upper limit of normal (ULN)
- •Anticoagulation treatment with heparin or vitamin K allowed if the above criteria are met
- •Liver transaminases ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)
- •Total bilirubin ≤ 1.5 times ULN
- •Serum creatinine ≤ 1.5 times ULN
- •Amylase and lipase ≤ 1.5 times ULN
- •Not pregnant or nursing
- •Weight loss from pre-disease weight < 20% over the past 12 months
- •Able to swallow
- •No active or ischemic coronary artery disease
- •No myocardial infarction within the past 6 months
- •No NYHA class III-IV cardiac failure
- •No uncontrolled hypertension
- •No coagulopathy
- •No active uncontrolled peptic ulcer
- •No patients on renal dialysis
- •No active bacterial or fungal infection > CTCAE v3.0 grade 2
- •No HIV or hepatitis B or C positivity
- •No chronic unstable illness that could jeopardize patient safety or compliance
- •No other progressive or malignant tumor
- •No known or suspected allergy to sorafenib tosylate
- •No psychological, familial, social, or geographic situations that preclude clinical follow up
- •No patients deprived of liberty or under guardianship
- •No cardiac arrhythmia requiring antiarrhythmic medication (except beta-blockers or digoxin for chronic atrial fibrillation)
- •No epilepsy requiring antiepileptic drugs
- •PRIOR CONCURRENT THERAPY:
- •See Patient Characteristics
- •No prior organ or peripheral stem cell transplantation
- •No more than 2 prior lines of chemotherapy
- •At least 28 days since prior treatment (systemic or major surgery)
- •No concurrent therapy for another malignancy
- •No concurrent CYP3A inducers (e.g., rifampicin, St. John wort, phenytoin, carbamazepine, phenobarbital, dexamethasone)
排除标准
- 未提供
结局指标
主要结局
Rate of non-progression at 9 months by RECIST criteria
次要结局
未报告次要终点
研究者
研究点 (20)
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